Amneal Announces FDA Approval For Spironolactone HCl Tablets
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Also Included In: Regulatory Affairs / Drug Approvals
Amneal Pharmaceuticals, LLC is pleased to denote that it has standard U.S. FDA commendation to fabrication Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effectual July 2, 2010. The Amneal generic is an AB-rated, therapeutically eq choice to Aldactone® (a registered brand of Pharmacia & Upjohn, Inc., a whole of Pfizer Inc.). Annual U.S. sales of Spironolactone HCl were $91 MM as of December 2009 according to IMS Health marketplace information.
Spironolactone HCl is a celluloid 17-lactone dose that is a nephritic militant aldosterone resister in the grade of pharmaceuticals known as potassium-sparing diuretics. It is indicated in the direction of basal aldosteronism, dropsical weather (for patients with congestive spirit nonstarter , cirrhosis of the liver-colored attended by hydrops and/or ascites, the renal syndrome), requirement hypertension , hypokalemia and grave spirit nonstarter (NYHA category III-IV).
Amneal began transport Spironolactone HCl in 100- and 500-count sizes on July 21, 2010. The 25 mg durability can too be logical in 1000-count sizing. This production is usable done wholesalers-distributors as swell as straightaway to the sell. The tablets are produced in the fellowship’s amply cGMP-compliant Hauppauge, NY adroitness. Amneal manufactures all of its own generics in the USA and continues to boom its U.S.-based product.
Spironolactone HCl is the virtually late improver to Amneal’s apace ontogenesis portfolio, listed in the party’s online catalogue of 250 products hither. Launched one year ago, the comp web catalogue is intentional for wanton client and patient accession to all-important data, images and lit such as ware outserts, labels, patient medicine guides, MSDS (substantial rubber information sheets) and high-resolution merchandise photos.
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